vitaflow™ transcatheter aortic valve system pre-market trial

Conditions: Aortic Valve Stenosis

Summary: this is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of microport™ cardioflow vitaflow™ transcatheter aortic valve system for the treatment of severe aortic stenosis.

this is a prospective, multi-center, single-arm clinical investigation for evaluation of the safety and effectiveness of the microport™ cardioflow vitaflow™ transcatheter aortic valve system in the treatment of severe aortic stenosis. the investigation has two phases. phase i（fim）：the fim stage is a prospective, multicenter, single-arm observational clinical investigation, aiming to evaluate the feasibility and safety of the microport™ cardioflow vitaflow™ transcatheter aortic valve system. a total of 10 patients will be enrolled and 30-day clinical outcomes will be collected. phase ii (pivotal)：the pivotal stage is a prospective, multi-center, single-arm clinical investigation with the performance goal, aiming to evaluate the safety and effectiveness of microport™ cardioflow vitaflow™ transcatheter aortic valve system for the treatment of severe aortic stenosis. a total of 110 patients will be enrolled in 11 clinical centers across china. clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2 to 5 years annually post-procedure.

Eligibility criteria:
inclusion criteria : enrollment was limited to patients who met all of the following criteria: 1. age ≥ 70 years old(phase ii)/age ≥18 years old,male or female who are not pregnant (phase i); 2. patients have severe aortic stenosis: mean gradient\> 40mmhg(1mmhg = 0.133kpa), or peak velocity\> 4m/s, or an aortic valve area(ava) \<1.0 cm² (or ava index \<0.6 cm²/m²); 3. nyha classification ≥ ii; 4. life expectancy\> 12 months; 5. anatomically suitable for transcatheter aortic valve implantation; 6. assessed by a multidisciplinary heart team as a patient unsuitable for surgical aortic valve replacement; 7. patients who can understand the purpose of the investigation, volunteer to participate in and sign the informed consent form, and are willing to comply with relevant examinations and follow-up visits. exclusion criteria: 1. acute myocardial infarction occurred within 30 days before the treatment; 2. patients with congenital unicuspid aortic valve or aortic root anatomy and lesions that are not suitable for transcatheter valve implantation; 3. any therapeutic heart surgery within 30 days; 4. mixed aortic valve disease(aortic stenosis with severe regurgitation); moderate and severe mitral stenosis; severe mitral regurgitation; severe tricuspid regurgitation; 5. blood dyscrasia, including neutropenia (wbc \< 3 × 10\^9/l), acute anemia(hb \<90 g/l), thrombocytopenia(plt \<50 × 10\^9/l), hemorrhagic constitution, and coagulopathy disease; 6. untreated coronary artery disease requiring revascularization; 7. hemodynamic instability requiring systolic support or mechanical heart assistance; 8. need for emergency surgery for any reason; 9. obstructive hypertrophic cardiomyopathy; 10. severe left ventricular dysfunction, left ventricular ejection fraction(lvef) \< 20%; severe pulmonary hypertension and right ventricular dysfunction; 11. echocardiography suggests the presence of intracardiac masses, thrombi, or neoplasms; 12. active peptic ulcer or history of upper gastrointestinal bleeding within 3 months; 13. allergy to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or contrast agents; 14. cerebrovascular events including transient ischemic attack(tia) occurred within 6 months; 15. renal insufficiency decompensation(end creatinine clearance \< 20ml/min), and / or end-stage renal disease require long-term dialysis treatment; 16. vascular diseases affecting device access; 17. active infectious endocarditis or other active infection; 18. participated in clinical investigations of other drugs or medical devices before the election, and had not completed the primary endpoint; 19. the investigator judged that the patient had poor compliance and could not complete the study as required.